B. Braun Perifix FX Continuous Epidural Set Recalled for Connector Leakage
B. Braun Medical is recalling 1,032 Perifix FX Continuous Epidural Sets because the catheter connectors may not stay closed, leading to leakage or disconnection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect (leakage/disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 1,032 units of the CE17TF Perifix FX Continuous Epidural Set, Material Number 332234. The affected batches are 61589584, 61617132, and 61622878. This product is a connection device used by physicians to provide a single access point to a catheter for the continuous administration of anesthetic fluids.
The recall was initiated because the catheter connectors may not stay closed during use. In some cases, leakage or disconnection of the catheters from the connectors has been observed. This defect could compromise the delivery of anesthetics.
The affected units were distributed nationwide in the United States and in Australia, Canada, Guatemala, and Kuwait. Healthcare facilities and users should stop using the affected devices and contact B. Braun Medical for instructions on return or replacement.
The recalled product
- Product
- CE17TF PERIFIX FX CONTIN. EPIDURAL SET, Material Number 332234 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunctio
- Manufacturer
- B. Braun Medical, Inc.
- Hazard
- Affected units
- 1,032
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch: 61589584
- 61617132
- 61622878
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 93 recalled by B. Braun Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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